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Drug Approval

ImmunityBio Advances Marketing Authorization Applications for BCG-Unresponsive NMIBC CIS in Europe and the UK

Marketing authorization application for BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in situ (CIS) submitted to Europ...

January 16, 2025 | News

China Approves Sarclisa-Pd for Relapsed Multiple Myeloma, Backed by Pivotal Trial and Real-World Data.

Approval based on positive pivotal ICARIA-MM phase 3 study using the China-based IsaFiRsT real-world study as bridging data, which demonstrated Sarclisa ...

January 13, 2025 | News

SN BioScience Secures FDA IND Clearance for SNB-101 Phase 1b/2 Trial, Targeting Extensive Stage Small Cell Lung Cancer

SN BioScience announced that its lead asset SNB-101 has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administra...

January 13, 2025 | News

MSD’s GARDASIL® Becomes First HPV Vaccine Approved for Males in China

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the National Medical Products Administration (NMPA) of China ...

January 10, 2025 | News

Dizal’s China-Origin Sunvozertinib Secures FDA Priority Review for EGFR Exon20ins NSCLC

If approved, Sunvozertinib as a single oral drug would offer a convenient and safe treatment option with superior efficacy for NSCLC patients with E...

January 08, 2025 | News

Norgine Submits Marketing Authorisation Application to EMA for Eflornithine in High-Risk Neuroblastoma

Norgine announced that it completed its marketing authorisation application filing to European Medicines Agency (EMA) for eflornithine in high-risk ne...

January 07, 2025 | News

Astellas Pharma Announces NMPA Approval of Zolbetuximab in China for Advanced Gastric and GEJ Cancer

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the National Medical Products Administration (N...

January 06, 2025 | News

Everest Medicines Announces NEFECON® NRDL Implementation in China to Expand Access for IgAN Patients

Everest Medicines (HKEX 1952.HK, 'Everest', or the 'Company'), a biopharmaceutical company focused on the discovery, clinical development, manufacturing an...

January 06, 2025 | News

Japan Approves TEPOXX as First Antiviral Treatment for Orthopoxviruses, Including Smallpox, Mpox, and Cowpox

Regulatory decision marks first approval in Japan of an antiviral for the treatment of orthopoxviruses including smallpox, mpox and cowpox Japan Bi...

January 03, 2025 | News

Verastem Oncology’s NDA for Avutometinib-Defactinib Combo in KRAS Mutant LGSOC Accepted by FDA with Priority Review

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced that the U.S. Food a...

January 02, 2025 | News

Takeda’s HYQVIA Becomes First Facilitated Subcutaneous Immunoglobulin Approved in Japan for Immune Deficiency Disorders

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is the First and Only Facilitated Subcutaneous Immunoglobulin (f...

December 30, 2024 | News

Alphamab Oncology Receives NMPA Approval for Phase I/II Trial of Groundbreaking Subcutaneous Co-Formulation JSKN033

Alphamab Oncology (stock code: 9966.HK) announced that a phase I/II clinical trial (Study ID: JSKN033-102) of JSKN033, a high-concentration subcutaneous co...

December 27, 2024 | News

Keymed Biosciences Secures NMPA Approval for Stapokibart to Treat Chronic Rhinosinusitis with Nasal Polyposis

Keymed Biosciences Inc. announced the National Medical Products Administration (the "NMPA") of China has recently approved the supplemental New D...

December 24, 2024 | News

Vertex Announces FDA Approval of ALYFTREK™: A Once-Daily CFTR Modulator for Cystic Fibrosis Patients Aged 6 and Older

ALYFTREK™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not re...

December 23, 2024 | News

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